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Isosorbide mononitrate Pregnancy and Breastfeeding Warnings

Brand names: Imdur, Ismo, Monoket

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Isosorbide mononitrate Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: C/B (manufacturer dependent)

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Isosorbide mononitrate Breastfeeding Warnings

Use is not recommended. (AU)

Caution is recommended and this drug should be used only if the benefits outweigh the risks. (UK, US)

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comment: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. (2002) "Product Information. ISMO (isosorbide mononitrate)." Wyeth-Ayerst Laboratories
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2002) "Product Information. ISMO (isosorbide mononitrate)." Wyeth-Ayerst Laboratories
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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